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Lenacapavir API

Product Name:Lenacapavir
CAS.NO:2189684-44-2
structural formula:C39H32ClF10N7O5S2
Other names:GS-6207;Lenacapavir;
Test Method:HPLC/UV/GC-MS
MOQ & Package: 10g,100g,1kg,5kg,10kg,25kg etc
Customer's rights and interests:Over 10kg, you can enjoy the service of giving away free samples.
Certificate:FDA,ISO,COA, HPLC, MSDS,TDS etc
Lead Time: 1-3 days
Shipping: DHL,Germany DHL,Germany DPD,UPS,USPS,FedEx,EMS,By Air,By Sea,multimodal transport etc
Store & Shelf life; Cool & dry place; 36 months
Company advantages: there are self-built overseas warehouses and third-party overseas warehouses on all continents.
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  • Product Description

Xi'an Faithful BioTech Co., Ltd: Your Trusted Lenacapavir API Manufacturer & Supplier

Lenacapavir API powder, as the first HIV capsid inhibitor, provides a breakthrough treatment option for patients with multidrug-resistant HIV-1 infection. Its long-lasting properties significantly improve patient compliance. In addition, the Lenacapavir powder Xi'an Faithful BioTech Co., Ltd provide has a unique mechanism of action that avoids cross resistance with other antiretroviral drugs while exerting its effects, bringing revolutionary progress to the field of HIV treatment.

Lenacapavir API powder Introduction

Lenacapavir is the first inhibitor targeting HIV-1 capsid protein, which interferes with the virus lifecycle through a multi-stage mechanism of action

1.Inhibiting virus assembly: preventing the correct assembly of new virus particles in the late stage of the replication cycle
2.Interference with viral capsid shedding: Inhibiting capsid shedding in the early stages of infection and preventing viral RNA release
3.Block nuclear import: interfere with the process of virus entering the nucleus and prevent virus DNA integration

This multi-target mechanism of action allows it to remain effective against existing drug-resistant HIV strains and has no known cross resistance with other antiretroviral drugs. In addition, its outstanding breakthrough lies in its ultra long lasting characteristics. Clinical research applications have shown that compared to traditional daily antiretroviral drugs, it significantly improves patient compliance. The usage regimen of 1/2 Lenacapavir API provided by most physicians can maintain blood drug concentration above the effective treatment level, avoiding the risk of blocking treatment failure due to forgetting and other reasons.

Specifications

Item

SpecificationsResults

Appearance

White powder

Complies

Identification

By IR

Complies

 

By HPLC

Complies

Solubility

In DMSO ≥100 mg/mL, the water solubility is low.

Complies

PH

4.5-6.8

5.5

Melting Point

587.0±50.0 °C

588.0°C

Mesh size

60 Mesh number

Complies

Water Content

≤ 1.00%

0.25%

Related Substances

Any individual impurity: ≤0.50%

0.14%

 

Total impurities: ≤1.00%

0.20%

Assay (HPLC basis on drying)

98.0%~102.0%

99.60%

Conclusion:Conform with enterprise specification (USP 41). 

Why Choose Us? 

We chose our Lenacapavir because we deeply understand your commitment and needs in the fight against HIV, and are committed to becoming your most reliable partner. Here are our core advantages:
1. Excellent quality and strict standards
High purity raw materials: We use raw materials that comply with international pharmacopoeia standards to ensure that the purity of each batch of Lenacapavir is>99.5%, ensuring product safety and effectiveness from the source.
Full chain quality control: From synthesis, purification to finished product packaging, we perform over 20 key quality control tests to ensure that the product fully meets the standards in terms of composition, stability, and microbial limits.
2. Professional dosage forms and technological advantages
Multi dosage form support: We provide market-oriented solutions that strictly follow standardized production processes to ensure consistency between batches.
Process rigor: We use low-temperature solid-state synthesis technology to significantly reduce impurity production and ensure that the drug's long-term sustained-release performance meets the requirements of the in vivo release curve.
3. Full traceability and compliance assurance throughout the process
Seamless traceability system: Each batch of products is equipped with an independent traceability code, supporting full process traceability from raw materials to finished products.
Compliance assurance: We strictly follow cGMP and ICH guidelines to ensure that our products comply with regulatory requirements in the target market during registration, production, and distribution.
4. Reliable supply and global services
Stable supply capability: We have the production capacity to produce raw materials and corresponding formulations of up to 100 kilograms per year, which can fully meet clinical research and commercial needs.
Professional logistics support: We provide customized packaging and temperature controlled transportation solutions, and collaborate with experienced logistics partners to minimize customs and transportation risks.
5. Customer centered service philosophy
Full technical support: We are equipped with a professional team to provide you with comprehensive support from product consultation, medication plan to adverse reaction management.
Quick response mechanism: In case of individual quality issues, we promise to initiate an investigation and provide a solution within 72 hours, including free exchange or refund, to effectively protect your rights.
We are well aware that choosing Lenacapavir is not only about choosing products, but also about choosing trust. We will work with you hand in hand to promote the progress of anti AIDS cause with excellent quality, reliable service and continuous commitment. Our email is: sales8@faithfulbio.com

Excellent clinical efficacy

1. Treatment of multidrug-resistant HIV
In the CAPELLA study, Lenacapavir combined with optimized background regimen was used to treat patients with multidrug-resistant HIV-1 infection. At 52 weeks, 83% of patients achieved viral load<50 copies/mL, and CD4+cell count increased by an average of 82 cells/μ L. These patients had previously received an average of 9 types of antiretroviral therapy, demonstrating significant efficacy of Lenacapavir in refractory patients.
2. Preventing HIV infection
In the PURPOSSE 1 and PURPOSSE 2 studies, Lenacapavir demonstrated a 100% preventive effect. Among the 2134 women receiving treatment, not a single case developed HIV infection, while multiple infections occurred in the control group. In male and gender diverse populations, the prevention effect has also achieved a 96% reduction in infection rates
Lenacapavir API powder is not only used for the treatment of multidrug-resistant HIV-1 infection, but also approved for pre exposure prophylaxis (PrEP) of HIV, achieving the integration of treatment and prevention. This dual indication makes it more widely applicable in HIV prevention and control.

Quality Control:

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R&D Results: 

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Packaging and Transportation:

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After-Sales Service: 

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Qualification Certification:

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Transaction Feedback: 

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Exhibition: 

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FAQ 

Q1: Will you reconfirm the product with us before shipment?                                                                                                                                                                                                                                                            Yes, absolutely. Prior to every shipment, we will proactively send you a pre-shipment confirmation. This will include details such as the product name, batch number, and quantity for your final verification. This is a mandatory step in our standard operating procedure to ensure 100% accuracy.
Q2: What if the package is detained by the customs?
While customs detention is a rare occurrence, we take it very seriously. To safeguard your interests, we strongly recommend purchasing our shipping insurance. In the unlikely event of a detention, the insurance will cover the declared value of the goods.
Furthermore, as part of our commitment to a seamless long-term partnership, we employ discreet and compliant packaging methods designed to minimize any potential issues during transit.
Q3: How do you treat quality complaint?
We treat all quality concerns with the utmost priority. Our commitment is twofold:
Open Communication & Swift Resolution:​ We will never evade responsibility. Our team will work closely with you to understand the issue thoroughly and propose a fair and optimal solution promptly.
Satisfaction Guarantee:​ If a quality problem is confirmed to be attributable to us, we will immediately arrange for a replacement shipment at no cost to you or provide a full refund, whichever you prefer.

Contact us

Lenacapavir powder has brought revolutionary breakthroughs to the field of HIV treatment and prevention through its innovative mechanism of action, ultra long acting dosing regimen, excellent clinical efficacy, and good safety. Its unique advantages make it an important supplement to current antiretroviral drugs, particularly suitable for the prevention needs of multidrug-resistant patients and high-risk populations.
We are ready to provide more detailed technical information and business negotiations for your specific needs at any time. Welcome to contact us further. Our email address is:sales8@faithfulbio.com

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